Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy

NCT00515632 | Completed Phase 3

• 2 other identifiers: DRF2593-307EudraCT No. 2007-002088-29
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are at high risk of many serious diabetic complications, including cardiovascular disease, blindness, nerve damage and kidney damage. Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose compared to placebo, but with less impact on weight gain and oedema than pioglitazone (Actos®) 45 mg.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus on Stable insulin therapy; Balaglitazone; Pioglitazone (Actos®); HbA1c; Weight gain; Oedema; Fasting blood glucose

Outcome Measures

Primary Outcomes (1)

• HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters.

  baseline, 4, 8, 12, 17, 21 and 26 weeks

Secondary Outcomes (1)

• Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin

  baseline and 26 weeks

Study Arms (4)

Balaglitazone 10 mg per day

EXPERIMENTAL

Drug: Balaglitazone

Balaglitazone 20 mg per day

EXPERIMENTAL

Drug: Balaglitazone

Pioglitazone 45 mg per day

ACTIVE COMPARATOR

Drug: Balaglitazone

Placebo

PLACEBO COMPARATOR

Drug: Balaglitazone

Interventions

Balaglitazone DRUG

One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.

Balaglitazone 10 mg per day; Balaglitazone 20 mg per day; Pioglitazone 45 mg per day; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO criteria for at least 3 months
• Age ≥ 18 years
• BMI ≥ 25.0 kg/m2
• HbA1c ≥ 7.0 %
• Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least 75 days

You may not qualify if:

• Prior or current use of any PPAR-γ agonist
• Recent use (\< 3 months) of an investigational drug
• Pre-existing medical condition judged to preclude safe participation in the study
• Contraindication/intolerance to study medication
• Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
• Diagnosed or receiving medication for heart failure, NYHA I to IV
• Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention
• Uncontrolled treated/untreated systolic blood pressure \>180 mmHg and/or diastolic blood pressure \> 95 mmHg
• Known diabetic macular oedema
• Hematuria
• Serum creatinine \>130 μmol/l
• ALT, AST, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal
• Haemoglobin significantly (in the Investigators opinion, but not more than 1 mmol/L) below the lower limit of normal or haemoglobinopathy interfering with valid HbA1c assay
• Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives)
• Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation

Sponsors & Collaborators

• Rheoscience A/S: lead

Study Sites (1)

Multi-center

Copenhagen, Denmark

Location

Related Publications (1)

• Henriksen K, Byrjalsen I, Qvist P, Beck-Nielsen H, Hansen G, Riis BJ, Perrild H, Svendsen OL, Gram J, Karsdal MA, Christiansen C; BALLET Trial Investigators. Efficacy and safety of the PPARgamma partial agonist balaglitazone compared with pioglitazone and placebo: a phase III, randomized, parallel-group study in patients with type 2 diabetes on stable insulin therapy. Diabetes Metab Res Rev. 2011 May;27(4):392-401. doi: 10.1002/dmrr.1187.

  PMID: 21328517 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Weight Gain; Edema

Interventions

balaglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bente J Riis, MD

  Nordic Bioscience Clinical Studies A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 14, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 23, 2010

Record last verified: 2010-07

Locations

DK (1)